B-System Silicone is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

Device Description

The device is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

AI/ML Overview

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and an FDA clearance letter for a dental impression material named "B-System Silicone," which focuses on establishing substantial equivalence to a predicate device for market clearance.

The text does not include:

A table of acceptance criteria and reported device performance.
Details on sample sizes or data provenance for any test set.
Information on the number or qualifications of experts for ground truth establishment.
Adjudication methods.
Any multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone algorithm performance.
The type of ground truth used.
Training set sample size or how its ground truth was established.

The content primarily describes the device, its intended use, and its substantial equivalence to another legally marketed device, which is the basis for its FDA clearance.

Summary

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OCT 6 1998

SYBRON DENTAL SPECIA

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: August 1998

Device Name:

Trade Name B-System Silicone .
Common Name Silicone Impression Material .
Classification Name Impression Material, per 21 CFR § 872.3660 .

Devices for Which Substantial Equivalence is Claimed:

Heraeus Kulzer, Inc., CutterSil® Polysiloxane Impression Materials .

Device Description:

The device is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

Intended Use of the Device:

The intended use of B-System Silicone is for dental impressions of full dentures, partial dentures, inlays, onlays, crowns and bridges.

Substantial Equivalence:

B-System Silicone is substantially equivalent to several other legally marketed devices in the United States. The condensation cured elastomeric impression material marketed by Heraeus Kulzer, Inc. functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Corporation.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 1998

Ms. Colleen Boswell Senior Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re : K982917 B-System Silicone Trade Name: Regulatory Class: II Product Code: ELW Dated: August 18, 1998 Received: August 19, 1998

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions-The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control,

and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section I - Indications for Use

510(k) Number:

K982917

Device Name:

B-System Silicone

Indications for Use:

B-System Silicone is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).